The newly revised Drug Administration Law of China to take effect on December 1, 2019 for better regulation of drug production
2019.11.18
The newly revised Drug Administration Law of the people's Republic of China was adopted by the 12th meeting of the Standing Committee of the 13th National People's Congress to better regulate drug production. The revised Drug Administration Law has a total of 12 chapters and 155 articles, which has increased the penalties for drug violations. In OKCHEM, we will also updated our related product listing policy for pharmaceuticals & biochemicals products. This law is applicable to the activities of drug research and development, drug production, marketing, use, supervision and administration within the territory of the people's Republic of China. The law will come into force on December 1, 2019. The newly revised Drug Administration Law of the people's Republic of China redefines what is fake medicine and inferior medicine. Article 98 clearly stipulates that fake drugs include drugs containing ingredients that are not in conformity with those specified in the national drug standards, drugs that are not drugs that are passed off as drugs or other drugs that are passed off as such, drugs that are deteriorated, and drugs with indications or functions that are beyond the prescribed scope. Inferior drugs include: drugs whose ingredients do not conform to the national drug standards, drugs that are contaminated, drugs that are not marked or have their expiry date changed, drugs that are not marked or have their batch number changed, drugs that are beyond their expiry date, drugs that are added with preservatives or auxiliary materials without authorization, and other drugs that do not conform to the drug standards. In drug production business, it is prohibited to produce or import drugs without obtaining drug approval certificates, and to use APIs, packaging materials and containers that are not reviewed and approved in accordance with regulations to produce drugs. Article 124 of the newly revised Drug Administration Law of the people's Republic of China also clearly states that certain drugs need to be sold and used, and they need to be held responsible under certain circumstances, including: production and import of drugs without obtaining drug approval documents, production of drugs with raw materials without review and approval, etc. if the sales or use unit uses the above drugs in violation of regulations, it shall be punished in accordance with the provisions of the preceding paragraph; if the circumstances are serious, the legal representative, main person in charge, directly responsible person in charge and other responsible personnel of the drug use unit shall have medical and health care If a person has a practice certificate, his practice certificate shall also be revoked. If a small amount of drugs that have been legally listed abroad are imported without approval, or if the circumstances are relatively minor, the punishment may be mitigated or exempted according to law. On OKCHEM, we have verified suppliers with valid drug production license. If you are in drug production business, you could check out our suggested suppliers. Zhejiang Davi Pharmaceutical Co., Ltd. Hunan Huari Pharmaceutical Co.Ltd Kaiping Genuine Biochemical Pharmaceutical Co., Ltd Related news in pharmaceutical industry Industry of Vitamin A: Supply Decrease and Market Demand Increase in Short Term Export of China's nutrition and health products in the first half of 2019 FDA: Biotin Supplements Could Affect Results of Medical Tests CPhI Annual Report predicts Europe to surpass the USA in biologic manufacturing capacity by 2023 FDA approves first therapy to treat patients with rare blood disorder Protein could offer therapeutic target for pancreatic cancer
모든 카테고리